The following data is part of a premarket notification filed by Teleflex Inc. with the FDA for Arrow Flexblock Continuous Peripheral Nerve Block Catheter Kit/set.
| Device ID | K153652 |
| 510k Number | K153652 |
| Device Name: | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set |
| Classification | Anesthesia Conduction Kit |
| Applicant | TELEFLEX INC. 3015 CARRINGTON MILL BLVD Morrisville, NC 27560 |
| Contact | Chet Jones |
| Correspondent | Chet Jones TELEFLEX INC. 3015 CARRINGTON MILL BLVD Morrisville, NC 27560 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-06-21 |
| Summary: | summary |